The efficacy and safety of Bazi Bushen Capsule in treating premature aging: A randomized, double blind, multicenter, placebo-controlled clinical trial.

Fuli Zhu, Chunxiao Ju, Biqing Wang, Shunlin Zhou, Erjun Liu, Wenying Zeng, Junnan Zhao, Luyao Huan, Yuxiao Huang, Jing Li, Huiyan Liu, Ran Luo, Shanfeng Gao, Qingxia Fang, YuHong Lu, Xueying Yin, Panbo Qiu, Yan Dong, Ruihua Zhao, Hong Meng, Yafeng Liu, Yanhong Zhang, Xiaoyuan Wang, Qi Yang, Qiaoning Yang, Yanfei Liu, Lirui Zhang, Ping Zhang, Rui Gao, Jiajun Zhao, Ying Zhang, Jun Mei, Fengqin Xu, Limin Yang

Journal: Phytomedicine : international journal of phytotherapy and phytopharmacology 2024;130():155742

PMID: 38838635

Full Text on Elsevier Science View on PubMed

Abstract

PURPOSE

It is unclear whether traditional Chinese patent medicines can resist premature aging. This prospective study investigated the effects of Bazi Bushen Capsule (BZBS) which is a traditional Chinese patent medicine for tonifying the kidney essence on premature senility symptoms and quality of life, telomerase activity and telomere length.

STUDY DESIGN AND METHODS

It was a parallel, multicenter, double-blind, randomized, and placebo-controlled trial. Subjects (n = 530) aged 30-78 years were randomized to receive BZBS or placebo capsules 12 weeks. The primary outcome was the clinical feature of change in kidney deficiency for aging evaluation scale (CFCKD-AES) and tilburg frailty indicator (TFI). The secondary outcomes were SF-36, serum sex hormone level, five times sit-to-stand time (FTSST), 6MWT, motor function test-grip strength, balance test, walking speed, muscle mass measurement, telomerase and telomere length.

RESULTS

After 12 weeks of treatment, the CFCKD-AES and TFI scores in the BZBS group decreased by 13.79 and 1.50 respectively (6.42 and 0.58 in the placebo group, respectively); The SF-36 in the BZBS group increased by 98.38 (23.79 in the placebo group). The FTSST, motor function test grip strength, balance test, walking speed, and muscle mass in the elderly subgroup were all improved in the BZBS group. The telomerase content in the BZBS group increased by 150.04 ng/ml compared to the placebo group. The fever led one patient in the placebo group to discontinue the trial. One patient in the placebo group withdrew from the trial due to pregnancy. None of the serious AEs led to treatment discontinuation, and 3 AEs (1.14%) were assessed as related to BZBS by the primary investigator.

CONCLUSIONS

BZBS can improve premature aging symptoms, frailty scores, and quality of life, as well as improve FTSST, motor function: grip strength, balance test, walking speed, and muscle mass in elderly subgroups of patients, and enhance telomerase activity, but it is not significantly associated with increasing telomere length which is important for healthy aging.

TRIAL REGISTRY

https://www.chictr.org.cn/showproj.html?proj=166181.

Address: Institute of geriatrics, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, PR China.; Institute of geriatrics, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, PR China; Graduate School, Beijing University of Chinese Medicine, Beijing, PR China.; Clinical Pharmacology Research Institute, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, PR China.; Department of Rehabilitation, Hebei Yiling Hospital, Shijiazhuang, 050000, PR China.; Department of Traditional Chinese Medicine, The First Hospital of Hebei Medical University, Shijiazhuang, 050000, PR China.; Department of Traditional Chinese Medicine, Tangshan Central Hospital, Tangshan, 063000, PR China.; International school of cosmetics, Beijing Technology and Business University, Beijing, 100048, PR China.; Department of Traditional Chinese Medicine, Shenzhen Third People's Hospital, Shenzhen, 518112, PR China.; Department of gynaecology, Guang'anmen Hospital China Academy of Chinese Medical Sciences, Beijing, 100053, PR China.; Department of Traditional Chinese Medicine, Shandong Provincial Hospital, Jinan, 250021, PR China.; Department of gynaecology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, PR China.; LNKMED Tech Co., Ltd, Beijing, 100000, PR China.; State Key Laboratory for Innovation and Transformation of Luobing Theory, Shijiazhuang, 050035, PR China.; Institute of geriatrics, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, PR China. Electronic address: [email protected].

DOI: 10.1016/j.phymed.2024.155742

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MeSH Terms: Humans, Double-Blind Method, Male, Drugs, Chinese Herbal, Middle Aged, Female, Aged, Quality of Life, Aging, Premature, Adult, Telomerase, Hand Strength, Prospective Studies, Telomere